Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 6, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Vulvar DiseasesHPV InfectionVulvar HSILPre-Cancerous DysplasiaHPV DiseaseVIN, Usual TypeVIN 2 of Usual TypeVIN 3 of Usual TypeVin IIVin IIIVIN Grade 2VIN Grade 3High Grade Intraepithelial Neoplasia
Interventions
DRUG

Artesunate ointment

topical ointment, as a non-surgical treatment

DRUG

Placebo ointment

topical placebo ointment

Trial Locations (5)

33905

RECRUITING

Florida Gynecologic Oncology, Fort Myers

44111

RECRUITING

Cleveland Clinic Fairview Hospital, Cleveland

44124

RECRUITING

Hillcrest Hospital, Mayfield Heights

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

46260

RECRUITING

Ascension St. Vincent, Indianapolis

Sponsors
All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

lead

Frantz Viral Therapeutics, LLC

INDUSTRY

NCT06075264 - Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3) | Biotech Hunter | Biotech Hunter